Standard Operating Procedure for Agitator Blade Changeover in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/106/2025 |
| Supersedes | SOP/ELX/106/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standard method for safely changing and verifying agitator blades in mixing vessels used for elixir manufacturing, depending on the type of product and process requirements.
2. Scope
This SOP applies to all changeover activities involving agitator blades for variable-speed and fixed-speed mixers in the Elixir Department.
3. Responsibilities
- Maintenance Technician:
- Perform changeover and verify secure installation of blades.
- Production Operator:
- Support blade changeover and ensure equipment is ready for use.
- Production Supervisor:
- Authorize blade changeover and inspect post-installation alignment.
- QA Officer:
- Verify and approve equipment status before batch startup.
4. Accountability
The Head of Engineering and Head of Production are jointly accountable for proper changeover and preventive maintenance of agitator blades and ensuring safe operation.
5. Procedure
5.1 Prerequisites
- Refer to the batch-specific process parameters to confirm if blade changeover is required (e.g.,
from paddle to turbine type).
Ensure the mixing vessel is cleaned and labeled “UNDER MAINTENANCE.”
Verify that the agitator motor is turned off and LOTO (Lockout/Tagout) is applied.
5.2 Removal of Existing Blade
- Wear appropriate PPE (gloves, goggles, safety shoes).
- Loosen the blade locking mechanism using the appropriate tool (e.g., wrench or torque spanner).
- Gently slide or unbolt the blade from the shaft and place it in a designated tray.
- Inspect the shaft and blade area for corrosion, cracks, or deformation.
5.3 Installation of New Blade
- Select the required blade type as per process specification (e.g., anchor, propeller, turbine).
- Visually inspect the new blade for cleanliness and physical integrity.
- Align the blade with the agitator shaft and secure it using the locking mechanism or bolts provided.
- Ensure that the blade is firmly fixed and centered.
5.4 Verification and Trial Run
- Remove all tools and confirm the work area is clear.
- Remove the LOTO tag and restore power supply.
- Run the agitator on minimum RPM for 30 seconds and observe for any abnormal noise or vibration.
- If acceptable, increase to working RPM and check for stability.
- Record observations in the Blade Changeover Log (Annexure-1).
5.5 Post-Changeover Activities
- Update the equipment status label to “READY FOR USE.”
- Production Supervisor to verify installation and sign off in the logbook.
- QA to review records before batch initiation.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- LOTO: Lockout Tagout
- PPE: Personal Protective Equipment
7. Documents
- Blade Changeover Log (Annexure-1)
- Equipment Maintenance Log
- Batch Manufacturing Record (BMR)
8. References
- WHO TRS 1010 – GMP Guidelines for Equipment
- 21 CFR Part 211.67 – Maintenance of Equipment
- OEM Manuals of Agitators
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Blade Changeover Log
| Date | Equipment ID | Old Blade Type | New Blade Type | Reason for Change | Technician | Supervisor |
|---|---|---|---|---|---|---|
| 11/04/2025 | MIX-104 | Turbine | Anchor | High Viscosity Batch | Rajesh Kumar | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included trial run step and blade type specification | Process Safety Enhancement | QA Head |